R-Med, Inc.: FDA clearances and approvals
R-Med, Inc. has 9 FDA 510(k) clearances (first 1994, latest 2000), across 6 product codes in 4 review panels. Median 510(k) review time: 98 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 4 | 4 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FHN | Ligator, Hemorrhoidal | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Obstetrics and Gynecology (4)
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
- Orthopedic (1)
Most recent R-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | FHN | 2000-07-17 | 90 |
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | HET | 1996-01-11 | 178 |
| K954882 | RIZA-RIBE NEEDLE (MODIFICATION) | HRX | 1995-11-16 | 98 |
| K953441 | RIZA-RIBE NEEDLE | FBK | 1995-08-18 | 32 |
| K950108 | R-MED MINI-RETRACTOR | HET | 1995-05-11 | 120 |
| K942411 | R-MED DISPOSABLE PLUG | HET | 1995-03-31 | 315 |
| K945637 | R-MED MOTORIZED LAPAROSCOPIC HANDLE | GCJ | 1994-12-07 | 21 |
| K943818 | MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS | GEI | 1994-08-29 | 24 |
| K935031 | RIZA-RIBE NEEDLE | HET | 1994-04-25 | 187 |
Recalls
openFDA lists no recalls under a recalling firm named R-Med, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does R-Med, Inc. have?
R-Med, Inc. has 9 FDA 510(k) clearances (first 1994, latest 2000), across 6 product codes in 4 review panels.
How long does FDA take to clear R-Med, Inc.'s 510(k)s?
The median time from FDA receipt to decision across R-Med, Inc.'s cleared 510(k)s is 98 days.
What devices does R-Med, Inc. make?
Its most frequent FDA product codes are HET (Laparoscope, Gynecologic (And Accessories), 4); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FHN (Ligator, Hemorrhoidal, 1).
Has R-Med, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching R-Med, Inc. Related entities may recall under other names.
Next steps
- See all 9 R-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, R-Med, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.